Denttio, Inc.

CLOSEOUT LETTER Denttio, Inc. MARCS-CMS 508595 — April 10, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Denttio, Inc. United States Issuing Office: United States Office of Medical Device and Radiological Health Operations, Division 3 19701 Fairchild Road, Irvine, CA 92612 VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED April 10, 2018 Mr. Young Han, President Denttio, Inc. 116 N. Maryland Ave., Suite 125 Glendale, CA 91206 Dear Mr. Han: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #16-17), dated 02/23/2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Kelly D. Sheppard Compliance Branch Director Division 3/West Office of Medical Device and Radiological Health Operations Content current as of: 04/20/2018